QC Bioanalytical Analyst
QC Bioanalytical Analyst
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Job Description
About PSC Biotech
Who are we
PSC Biotech is a leading Biotech Consultancy firm founded in 1996 headquartered in Pomona California USA with Global operations in Ireland India Singapore Australia and the US serving 350 clients in more than 23 countries worldwide. We provide cloudbased software solutions for Quality Management and Regulatory Inspections pharmaceuticals contract manufacturing professionals and metrology services to our clients.
Take your Career to a new Level
PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of likeminded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diversecultural work setting.
Employee Value Proposition
Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client s expectations with regards to quality of all scalable and business unit deliverables staying under budget and ensuring timelines for our deliverables are being met.
Overview:
QC Bioanalytical Analyst responsible for performing analytical testing within the Biologics laboratory
Requirements
Role Functions:
- Executing and Supporting routine analytical testing with assays such as HPLC Analysis (IEX SEC RPLC) UV analysis Capillary Electrophoresis (CE) PCR testing Bioassay methods (ELISA methods) and a wide range of compendial methods on Release Inprocess Stability samples in compliance with GMP requirements.
- Executing and Supporting routine analytical testing with Raw materials onsite.
- Follow uptodate practices with reference to pharmacopoeias specifications regulations and industry standards.
- Support the laboratory testing schedule to achieve an efficient QC system.
- Receive and manage samples that come into the lab for stability inprocess and release testing.
- Reagent preparation cleaning and routine equipment maintenance.
- Maintain good housekeeping and hygiene within the laboratory.
- Calibrate and maintain all designated laboratory instruments.
- Participate in risk assessments inspections audits incident investigations etc. and implement and followup on corrective / preventative measures.
- Ensure training is current for all job functions performed.
- Order stock and receive laboratory supplies.
- Maintain data integrity and ensure compliance with company SOPs specifications and cGMP regulations.
- Ensure that cGMP standards are maintained at all times.
- Promote and participate the implementation and maintenance of the relevant safety programs.
Experience Knowledge & Skills:
- 1 5 years laboratory testing experience in the Pharmaceutical industry.
- Relevant experience and skill sets in their area of expertise that adds value to the business; ideally in a manufacturing preferably in a GMP setting.
- Experience and critical skills in the area of expertise that add value to the business; ideally bioassay and DNA testing chemistry testing and raw material testing.
- Knowledge of regulatory/ code requirements to Irish European and International Codes Standards and Practices.
- Knowledge of cGMP & Laboratory Quality Systems.
- Effective communication presentation and interpersonal skills to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
Qualifications & Education:
- Qualification in Science/Chemical Engineering/Biological Engineering
#LIDM2
1 - 5 years laboratory testing experience in the Pharmaceutical industry. Relevant experience and skill sets in their area of expertise that adds value to the business; ideally in a manufacturing, preferably in a GMP setting. Experience and critical skills in the area of expertise that add value to the business; ideally bioassay and DNA testing, chemistry testing and raw material testing. Knowledge of regulatory/ code requirements to Irish, European and International Codes, Standards and Practices. Knowledge of cGMP & Laboratory Quality Systems. Effective communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
Education
1 - 5 years laboratory testing experience in the Pharmaceutical industry. Relevant experience and skill sets in their area of expertise that adds value to the business; ideally in a manufacturing, preferably in a GMP setting. Experience and critical skills in the area of expertise that add value to the business; ideally bioassay and DNA testing, chemistry testing and raw material testing.
Employment Type
Full Time
